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RU2008132846A - S-Adenosylmethionine Compositions for Oral Administration - Google Patents

S-Adenosylmethionine Compositions for Oral Administration Download PDF

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RU2008132846A
RU2008132846A RU2008132846/15A RU2008132846A RU2008132846A RU 2008132846 A RU2008132846 A RU 2008132846A RU 2008132846/15 A RU2008132846/15 A RU 2008132846/15A RU 2008132846 A RU2008132846 A RU 2008132846A RU 2008132846 A RU2008132846 A RU 2008132846A
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inositol
weight
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RU2008132846/15A
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RU2427376C2 (en
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Алессандро СЕНЕЧИ (IT)
Алессандро СЕНЕЧИ
Даниэле ДЖОВАННОНЕ (IT)
Даниэле Джованноне
Чезаре ЦИО (IT)
Чезаре ЦИО
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Грааль Срл (It)
Грааль Срл
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Abstract

1. Пищевая и/или нутрицевтическая фармацевтическая композиция для перорального применения, содержащая S-аденозилметионин-пара-толуолсульфонат в сочетании с инозитолом и/или его производными и фармацевтически приемлемыми эксципиентами. ! 2. Композиция по п.1, в которой указанный инозитол и/или производные представляют собой инозитол как таковой, инозитол-6-фосфат или их смесь. ! 3. Композиция по п.1, в которой SAMe содержится в количестве, которое изменяется от приблизительно 10 до приблизительно 90% по весу по отношению к весу композиции. ! 4. Композиция по п.3, в которой SAMe содержится в количестве, которое изменяется от приблизительно 10 до 50% по весу по отношению к весу композиции. ! 5. Композиция по п.1, в которой инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 50 до приблизительно 90% по весу по отношению к весу композиции. ! 6. Композиция по п.1, в которой инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 30 до приблизительно 85% по весу по отношению к весу композиции ! 7. Композиция по п. 1, содержащая по меньшей мере один другой активный компонент, предпочтительно выбранный из мелатонина, сухого экстракта зверобоя и сухого экстракта мяты лимонной или их смесей. ! 8. Композиция по п. 1, в которой по меньшей мере один из фармацевтически приемлемых эксципиентов представляет собой оксид магния. ! 9. Композиция по п. 1, в форме таблетки, капсулы, гранулы или порошка. ! 10. Композиция по п.8, в форме таблетки, предпочтительно простой, с оболочкой, с пленочным покрытием, многослойной и/или резистентной к желудочному соку таблетки. ! 11. Композиция по п.8, отличительн1. A food and / or nutraceutical pharmaceutical composition for oral administration containing S-adenosylmethionine-para-toluenesulfonate in combination with inositol and / or its derivatives and pharmaceutically acceptable excipients. ! 2. The composition according to claim 1, wherein said inositol and / or derivatives are inositol per se, inositol-6-phosphate, or a mixture thereof. ! 3. The composition according to claim 1, in which SAMe is contained in an amount that varies from about 10 to about 90% by weight relative to the weight of the composition. ! 4. The composition according to claim 3, in which SAMe is contained in an amount that varies from about 10 to 50% by weight relative to the weight of the composition. ! 5. The composition according to claim 1, in which the inositol and / or its derivatives are contained in an amount that varies from about 50 to about 90% by weight relative to the weight of the composition. ! 6. The composition according to claim 1, in which the inositol and / or its derivatives are contained in an amount that varies from about 30 to about 85% by weight relative to the weight of the composition! 7. The composition according to claim 1, containing at least one other active component, preferably selected from melatonin, dry extract of St. John's wort and dry extract of lemon mint or mixtures thereof. ! 8. The composition of claim 1, wherein at least one of the pharmaceutically acceptable excipients is magnesium oxide. ! 9. The composition of claim 1, in the form of a tablet, capsule, granule or powder. ! 10. The composition of claim 8, in the form of a tablet, preferably a simple, coated, film-coated, multilayer and / or gastric juice-resistant tablet. ! 11. The composition of claim 8, distinctive

Claims (29)

1. Пищевая и/или нутрицевтическая фармацевтическая композиция для перорального применения, содержащая S-аденозилметионин-пара-толуолсульфонат в сочетании с инозитолом и/или его производными и фармацевтически приемлемыми эксципиентами.1. A food and / or nutraceutical pharmaceutical composition for oral administration containing S-adenosylmethionine-para-toluenesulfonate in combination with inositol and / or its derivatives and pharmaceutically acceptable excipients. 2. Композиция по п.1, в которой указанный инозитол и/или производные представляют собой инозитол как таковой, инозитол-6-фосфат или их смесь.2. The composition of claim 1, wherein said inositol and / or derivatives are inositol per se, inositol-6-phosphate, or a mixture thereof. 3. Композиция по п.1, в которой SAMe содержится в количестве, которое изменяется от приблизительно 10 до приблизительно 90% по весу по отношению к весу композиции.3. The composition according to claim 1, in which SAMe is contained in an amount that varies from about 10 to about 90% by weight relative to the weight of the composition. 4. Композиция по п.3, в которой SAMe содержится в количестве, которое изменяется от приблизительно 10 до 50% по весу по отношению к весу композиции.4. The composition according to claim 3, in which SAMe is contained in an amount that varies from about 10 to 50% by weight relative to the weight of the composition. 5. Композиция по п.1, в которой инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 50 до приблизительно 90% по весу по отношению к весу композиции.5. The composition according to claim 1, in which the inositol and / or its derivatives are contained in an amount that varies from about 50 to about 90% by weight relative to the weight of the composition. 6. Композиция по п.1, в которой инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 30 до приблизительно 85% по весу по отношению к весу композиции6. The composition according to claim 1, in which inositol and / or its derivatives are contained in an amount that varies from about 30 to about 85% by weight relative to the weight of the composition 7. Композиция по п. 1, содержащая по меньшей мере один другой активный компонент, предпочтительно выбранный из мелатонина, сухого экстракта зверобоя и сухого экстракта мяты лимонной или их смесей.7. The composition according to p. 1, containing at least one other active component, preferably selected from melatonin, dry extract of St. John's wort and dry extract of lemon mint or mixtures thereof. 8. Композиция по п. 1, в которой по меньшей мере один из фармацевтически приемлемых эксципиентов представляет собой оксид магния.8. The composition of claim 1, wherein at least one of the pharmaceutically acceptable excipients is magnesium oxide. 9. Композиция по п. 1, в форме таблетки, капсулы, гранулы или порошка.9. The composition of claim 1, in the form of a tablet, capsule, granule or powder. 10. Композиция по п.8, в форме таблетки, предпочтительно простой, с оболочкой, с пленочным покрытием, многослойной и/или резистентной к желудочному соку таблетки.10. The composition of claim 8, in the form of a tablet, preferably a simple, coated, film-coated, multilayer and / or gastric juice-resistant tablet. 11. Композиция по п.8, отличительной особенностью которой является то, что она имеет форму резистентной к желудочному соку таблетки.11. The composition of claim 8, the distinguishing feature of which is that it is in the form of a tablet resistant to gastric juice. 12. Способ получения таблетки в соответствии с пп.1-10, который включает в себя стадии:12. A method of producing a tablet in accordance with claims 1-10, which includes the steps of: a) смешивания SAMe или его солей с фармацевтически приемлемыми эксципиентами;a) mixing SAMe or its salts with pharmaceutically acceptable excipients; b) предварительного прессования с последующей грануляцией смеси, полученной на стадии a);b) pre-pressing followed by granulation of the mixture obtained in stage a); c) покрытия гранулированного продукта, полученного на стадии b) гидрированными жирными кислотами;c) coating the granular product obtained in step b) with hydrogenated fatty acids; d) смешивания, предварительного прессования и грануляции инозитола и/или его производных с фармацевтически приемлемыми эксципиентами;d) mixing, pre-pressing and granulating inositol and / or its derivatives with pharmaceutically acceptable excipients; e) покрытия гранулированных продуктов, полученных на стадии d) гидрированными жирными кислотами;e) coating the granular products obtained in step d) with hydrogenated fatty acids; f) смешивания гранулированных продуктов, полученных на стадиях c) и e) с фармацевтически приемлемыми эксципиентами;f) mixing the granular products obtained in stages c) and e) with pharmaceutically acceptable excipients; g) прессования смеси, полученной на стадии f), с необязательным добавлением подсластителей и/или ароматических веществ;g) compressing the mixture obtained in step f), with the optional addition of sweeteners and / or flavorings; h) необязательного покрытия таблеток, полученных на стадии g) гидрированными жирными кислотами;h) optionally coating the tablets obtained in step g) with hydrogenated fatty acids; i) необязательного пленочного покрытия в водной фазе таблеток, полученных на стадии h).i) an optional film coating in the aqueous phase of the tablets obtained in stage h). 13. Способ по п.12, в котором SAMe представляет собой S-аденозилметионин-пара-толуолсульфонат.13. The method of claim 12, wherein SAMe is S-adenosylmethionine-para-toluenesulfonate. 14. Способ по п.12, в котором указанный инозитол и/или его производные представляет собой инозитол как таковой, инозитол-6-фосфат или их смесь.14. The method of claim 12, wherein said inositol and / or its derivatives is inositol per se, inositol-6-phosphate, or a mixture thereof. 15. Способ по п.12, в котором относительная влажность ниже приблизительно 25%, а температура поддерживается между приблизительно 20 и 30°C, в частности приблизительно 25°C.15. The method according to item 12, in which the relative humidity is below about 25%, and the temperature is maintained between approximately 20 and 30 ° C, in particular approximately 25 ° C. 16. Способ по п.12, в котором на стадии d) возможно добавление к смеси по меньшей мере одного другого активного компонента, предпочтительно выбранного из мелатонина, сухого экстракта зверобоя и сухого экстракта мяты лимонной и/или их смесей.16. The method according to item 12, in which at the stage d) you can add at least one other active component to the mixture, preferably selected from melatonin, dry St. John's wort extract and dry extract of lemon mint and / or mixtures thereof. 17. Способ по п.12, в котором покрытие, осуществляемое на стадии h), выполняют из гидрированных жирных кислот в количестве между 0,5 и 2,5% по весу по отношению к весу композиции.17. The method according to item 12, in which the coating carried out in stage h) is made of hydrogenated fatty acids in an amount of between 0.5 and 2.5% by weight relative to the weight of the composition. 18. Способ по п.12, в котором пленочное покрытие в водной фазе, осуществляемое на стадии i), выполняют из лака, предпочтительно выбранного из гуммилака и/или его солей (ShellacТМ), метакриловой кислоты, ацетофталатов целлюлозы, диоксида титана, талька, триэтилцитрата, PVP K30, рибофлавин-6-фосфата, гидроксипропилцеллюлозы, гидроксипропилметилцеллюлозы и/или их смесей.18. The method according to item 12, in which the film coating in the aqueous phase, carried out in stage i), is made of varnish, preferably selected from gummilak and / or its salts (Shellac TM ), methacrylic acid, cellulose acetate phthalates, titanium dioxide, talc , triethyl citrate, PVP K30, riboflavin-6-phosphate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and / or mixtures thereof. 19. Способ по п.12, в котором лак содержится в количестве в диапазоне от приблизительно 2,0 до приблизительно 8,0% по весу по отношению к композиции.19. The method according to item 12, in which the varnish is contained in an amount in the range from about 2.0 to about 8.0% by weight relative to the composition. 20. Способ по п.12, в котором на стадии i) возможно необязательное добавление масла мяты лимонной и/или зверобоя в количестве, которое изменяется от приблизительно 0,01 до приблизительно 0,2% по весу по отношению ко всей композиции.20. The method according to item 12, in which at stage i) optionally adding lemon peppermint oil and / or St. John's wort in an amount that varies from about 0.01 to about 0.2% by weight relative to the entire composition. 21. Пищевые и/или нутрицевтические фармацевтические композиции, получаемые посредством способа по пп.12-20.21. Food and / or nutraceutical pharmaceutical compositions obtained by the method according to PP-20. 22. Применение SAMe или его солей в сочетании с инозитолом и/или его производными для получения композиции для лечения депрессивных состояний и панических синдромов.22. The use of SAMe or its salts in combination with inositol and / or its derivatives to obtain a composition for the treatment of depressive conditions and panic syndromes. 23. Применение по п.22, в котором указанный SAMe представляет собой S-аденозилметионин-пара-толуолсульфонат.23. The use of claim 22, wherein said SAMe is S-adenosylmethionine-para-toluenesulfonate. 24. Применение по п.22, в котором указанный инозитол и/или его производные представляют собой инозитол как таковой, инозитол-6-фосфат или их смесь.24. The use of claim 22, wherein said inositol and / or its derivatives are inositol per se, inositol-6-phosphate, or a mixture thereof. 25. Способ стабилизации твердой пищевой и/или нутрицевтической фармацевтической композиции на основе SAMe или его солей, который включает в себя применение инозитола и/или его производных.25. A method of stabilizing a solid food and / or nutraceutical pharmaceutical composition based on SAMe or its salts, which includes the use of inositol and / or its derivatives. 26. Способ по п.25, в котором SAMe или его соли содержатся в количестве между приблизительно 10 и приблизительно 90% по весу в расчете по отношению к весу композиции.26. The method according A.25, in which SAMe or its salts are contained in an amount of between about 10 and about 90% by weight, based on the weight of the composition. 27. Способ по п.26, в котором SAMe или его соли содержатся в количестве между приблизительно 10 и приблизительно 50% по весу в расчете по отношению к весу композиции.27. The method according to p, in which SAMe or its salts are contained in an amount of between about 10 and about 50% by weight, based on the weight of the composition. 28. Способ по п.25, в котором инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 50 до приблизительно 90% по весу по отношению к весу композиции.28. The method according A.25, in which inositol and / or its derivatives are contained in an amount that varies from about 50 to about 90% by weight relative to the weight of the composition. 29. Способ по п.28, в котором инозитол и/или его производные содержатся в количестве, которое изменяется от приблизительно 50 до приблизительно 85% по весу по отношению к весу композиции. 29. The method according to p, in which inositol and / or its derivatives are contained in an amount that varies from about 50 to about 85% by weight relative to the weight of the composition.
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